OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1

OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1 is an FDA 510(k)-cleared medical device (K920908) manufactured by Teleflexmedical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 5, 1992. Regulation: 8.